Regulatory Affairs associates
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I am a dedicated and detail‑oriented Regulatory Affairs professional with a strong foundation in biochemistry, pharmaceutical documentation, and compliance. With over six years of experience supporting regulatory submissions, quality systems, and documentation processes, I bring a deep understanding of CTD/eCTD formats, Health Canada and FDA requirements, and GMP‑aligned workflows.
My background includes preparing and reviewing regulatory dossiers, coordinating cross‑functional documentation, and ensuring accuracy and compliance in all stages of the submission process. I am highly organized, quick to learn new systems, and committed to delivering high‑quality work in fast‑paced environments.
Having recently relocated to Canada, I am actively seeking opportunities to contribute to a pharmaceutical or biotech organization in a Regulatory Affairs Assistant or Associate role. I am passionate about regulatory compliance, continuous learning, and supporting teams that bring safe, effective products to patients
I am a Regulatory Affairs professional with over six years of experience supporting pharmaceutical submissions, documentation, and compliance activities for Health Canada, FDA, and international markets. My background includes preparing and reviewing CTD/eCTD dossiers, coordinating cross‑functional documentation, and ensuring regulatory accuracy across product lifecycles. I have worked extensively with GMP‑aligned processes, quality systems, labeling review, and change control documentation.
In addition to my regulatory experience, I have hands‑on exposure to pharmacy operations in Canada, where I strengthened my skills in data entry, customer service, and documentation accuracy. My academic foundation in biochemistry, combined with a postgraduate diploma in Quality Assurance & Regulatory Affairs, enables me to understand scientific data and regulatory requirements with clarity and precision.
I am highly organized, detail‑oriented, and skilled at managing multiple deadlines in fast‑paced environments. I am now seeking an opportunity to contribute to a pharmaceutical or biotech organization in a Regulatory Affairs Assistant or Associate role.
PG diploma in Regulatory Affairs and Quality Assurance
Biotechnology, biochemistry and chemistry
